Indications and uses
temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
do not take more than directed the smallest effective dose should be used drink a full glass of water with each dose if taken with food, this product may take longer to work adults and children 12 years and older take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules in a 2...
each capsule contains: sodium 20 mg store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F). read all directions and warnings before use. Keep carton. swallow whole; do not crush, chew, or dissolve
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Heart attack and stroke: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
take with food or milk if stomach upset occurs
ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222).
FD&C blue #1, gelatin, glycerin, lactic acid, lecithin, light mineral oil, n-butyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitan, sorbitol solution, titanium dioxide, white ink
Call toll free 1-888-423-0139
COMPARE TO ALEVE® ACTIVE INGREDIENT†
Naproxen Sodium Capsules, 220 mg
PAIN RELIEVER • FEVER REDUCER (NSAID)
Strength to lasts 12 hours
LIQUID-FILLED CAPSULES
†This product is not manufactured or distributed by Bayer HealthCare, LLC distributor of Aleve®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO PLVA0318
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 36800-748 | 36800-748-20, 36800-748-40, 36800-748-80 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LACTIC ACID | 33X04XA5AT | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| SORBITOL | 506T60A25R | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| SHELLAC | 46N107B71O | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208363-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | f41ea6bd6efb… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| c3e4419d-4fb7-4db6-9c76-212ecaac39f7 | e4696104-e701-4886-9932-e8eca02278eb | 2025-05-01 | Warnings | c3e4419d-4fb7-4db6-9c76-212ecaac39f7 e4696104-e701-4886-9932-e8eca02278eb |
Adverse event summaries are temporarily unavailable. Other product information remains available.